The Pharmaceutical Industry’s Role in the Climate Crisis
Climate change is not solely an environmental issue; it also poses a significant threat to both human health and economic stability. In a fact sheet released in October 2023, the World Health Organization estimated that the direct damage costs to health from climate change would reach U.S. $2–4 billion per year by 2030, while between 2030 and 2050, there would be an additional 250,000 deaths per year from undernutrition, malaria, diarrhea, and heat stress alone.1 The pharmaceutical and biopharmaceutical industries exist to positively impact human health through the development of lifesaving saving medications. This means that these industries have a unique opportunity to contribute to improving public health in two distinct ways; through both what they do (developing new medicines), and how they do it (implementing more sustainable business practices).
The need to take action on climate change is widely recognized by pharmaceutical companies and their stakeholders, many of whom have now established clear environmental and social governance (ESG) policies and made bold environmental commitments. However, a 2022 Report by the Deloitte Centre for Health Solutions found that, despite these ambitious goals, much of the industry is still struggling with a disconnect between aspiration and action.2
This is hardly surprising given the scale of the challenge the industry faces to reduce its environmental impact. While emphasis and responsibility for reducing environmental impact has historically focussed on obviously emission-intensive industries, such as mining, energy and automotives, in fact the pharmaceutical industry releases over 55% more carbon dioxide equivalent (CO2e) per million dollars of revenue than the automotive industry.3 Meanwhile, healthcare as a whole has a climate footprint equivalent to 4.4% of global net emissions. In other words, if the healthcare sector was a country, it would be the fifth largest greenhouse gas emitter on the planet.4
The Greenhouse Gas Protocol sets corporate standards for measuring, managing, and reporting emissions, which they define within three different categories. Scope 1 covers direct emissions from company owned or controlled sources, for example heating offices or fueling vehicles. Scope 2 encompasses indirect emissions from producing the energy a company purchases. Scope 3 emissions are all other indirect emissions that occur in the reporting company’s value chain, for example business travel, employee commuting and disposal of products from third party suppliers.5
While most pharmaceutical companies put the heaviest emphasis on Scopes 1 and 2, Scope 3 emissions are often the biggest contributor to an organization’s greenhouse gas emissions.2 The problem of plastic waste in the pharma/biopharmaceutical industry sits firmly within Scope 3.
Plastic Waste is the Elephant in the Room of Sustainability Conversations
The amount of plastic waste generated within life sciences is difficult to quantify, and various estimates are regularly quoted, although the data these references are based on are not easily available. Scientists in the Biosciences Department of Exeter University in the UK estimated that their department disposed of 267 tons of plastic in 2014 alone. Extrapolating that to encompass approximately 20,500 academic institutions worldwide who are involved in biological, medical, or agricultural research suggests that these labs could have been responsible for 5.5 million tons of plastic waste in 2014.6 MilliporeSigma estimate that the biopharmaceutical industry disposes of between 94,000 and 200,000 metric tons of plastic each year,7 while elsewhere, sources suggest that the pharmaceutical industry may be responsible for as much as 300 million tons of plastic waste each year.8,9 Disposable lab plasticware is often considered a “necessary evil” to ensure product safety and eliminate contamination risks, as well as for the cost and time savings it allows. However, the volume of plastic waste generated by the life sciences industry is becoming both more apparent, and more frequently remarked upon, as utilization of single-use technologies for biopharmaceutical manufacturing increases.
Single-use manufacturing platforms have become the gold standard for many biopharma applications, including monoclonal antibodies (mAbs), viral vectors, and cell therapies. Replacing fixed stainless-steel fermenters, tanks, downstream equipment, and piping with single-use alternatives confers many benefits. The risk of cross-contamination between batches or products is eliminated. Extensive cleaning and steam sterilization protocols are no longer needed between production runs, which improves efficiency. Manufacturing suites can be reconfigured to suit the needs of different products. The costs associated with plant maintenance are much reduced.10 Moreover, life cycle assessment comparisons between fixed and single-use process technology have demonstrated that single-use technologies actually have an overall lower environmental impact than traditional fixed equipment. This is predominantly due to a significant reduction in chemical, energy, and water consumption when water-for-injection, process water, and clean steam are no longer required for inter-batch sterilization and cleaning routines.11 In fact, a disposable-based facility consumes 87% less water and 30% less energy than a stainless-steel facility.12
However, this doesn’t get away from the fact that single-use facilities generate an enormous amount of plastic waste; using a 2000-L single-use bioreactor to manufacture mAbs uses 767.5 kg plastic per batch (including resins, bags and tubing, filters, and packaging), compared to manufacturing in stainless-steel bioreactor, which uses only 252.5 kg plastic per batch.13 While single-use systems contribute only a fraction of the laboratory plastic disposed of each year by the pharmaceutical industry, the uptick in their use has been an important catalyst for the industry to consider how to solve the problem of pharmaceutical plastic waste.
Reduce, Reuse, Recycle: A Three-Pronged Approach to Decreasing Pharmaceutical Plastic Waste
To reach net zero, pharmaceutical and biopharmaceutical companies will have to make sweeping changes to existing processes, business models, and supply chains. For many companies, it will require reducing emissions by as much as 90%.2 This will be a substantial undertaking, and one for which there is no quick or easy solution. However, it’s also an area that is attracting significant interest, investment, and innovation. Here, we explore some novel solutions to facilitate a reduction in laboratory plastic waste: replacing fossil-fuel based plastics with bioplastic alternatives; solutions that enable previously single-use plastic consumables to be reused, and recycling schemes for plastics from even biosafety level (BSL) 1 and 2 labs.
Reduce: Replacing Fossil Fuel–Based Plastics with Bioplastic Alternatives
One solution to reducing our reliance on fossil fuel–based plastic is to switch to more environmentally friendly alternatives. Enter bioplastics. Plastics are defined as bioplastics if they are either biodegradable, biobased, or both. This broad definition means that not all bioplastics are without environmental challenges; some require specific conditions to decompose, others release methane as they do so, and still more raise questions about the impact of land use change, when crops are used for bio-fuels and materials rather than food.14 Therefore, rather than automatically considering bioplastics to have a lower environmental impact than fossil fuel–based plastics, it’s important to conduct full life cycle analyses for each application to ensure that the switch to bioplastics is contributing toward the move to net zero.
One area where bioplastics have shown particular promise is in medical devices, where materials such as polylactic acid (PLA), a bioplastic manufactured by polymerising lactic acid from renewable resources, such as corn starch, tapioca roots, chips or starch, and sugarcane, have shown particular benefits. PLA is one of the most easily biodegradable thermoplastics and degrades via hydrolysis, which makes it particularly well suited for applications such as surgical sutures, scaffolds for tissue engineering, dental wound healing, and postoperative adhesion prevention. Biocompatibility and biodegradability also mean that PLA is particularly well suited to single-use medical devices, such as syringes and catheters.15
PLA is also extremely well suited for use in cell culture applications. Dr. Joel Eichmann, founder and managing director of Green Elephant Biotech, designed a new system for adherent cell culture to address some of the issues facing cell stacks and roller bottles. These systems are difficult to scale due to their labor-intensive manual handling requirements, lack of online monitoring or automation capabilities, and the physical footprint required for large-scale culture systems. In the process, Dr. Eichmann discovered the benefits of PLA for cell culture applications.
“Adherent cell culture has many drawbacks, so that it’s usually preferable to transition to suspension cultures wherever possible. But for some cell types — for example induced pluripotent stem cells (iPSCs) or mesenchymal stem cells (MSCs), or in fact any other primary cell culture needed for autologous therapies, making a suspension culture just isn’t an option. So, we came up with the idea of combining cell stacks and roller bottles; we took a roller bottle and introduced two internal structures. The first is an Archimedian screw, so with a simple rotation, the culture media gets transferred through the Archimedian screw in the roller bottle. This is in contrast to a cell stack that needs to be tilted in three dimensions to evenly distribute the media. Then there’s a tube in the middle that controls that, so you get very good, very gentle, mixing with no shear stress, but an oxygen transfer rate comparable to a stirred-tank bioreactor. The second structure is concentric cylinders inside the flask, which generates a lot of surface area for the cells, such that a single 6,000-cm2 Cell Screw bottle has the equivalent surface area of a 10-layer Cell Stack. Overall, this is more compact, cheaper, gets better oxygen transfer rates, better mixing properties, and more homogeneous cell growth than a standard Cell Stack.”
“But the internal geometry is very complicated. You can’t use conventional manufacturing technology to make these bottles, so we decided to manufacture them using 3D printers, which meant screening for new materials. We screened initially for three main parameters. Is it biocompatible? Will it meet regulatory standards for plastic? And is it suitable for cell culture? For example, will the cells adhere to it, either with or without tissue culture treatment? And we came to PLA. A lot of cell lines grow on PLA even without treatment; in fact, the baseline for attachment is even better than for polystyrene, where nothing would attach without tissue culture treatment. PLA had the other advantage of having been used in biomedical device applications for years, so there was already medical-grade raw material available. At that point we realised that as a plant-based material, this was also likely to be more sustainable than a fossil-fuel based plastic, so we commissioned a third party to conduct a full life cycle analysis for us, and of course, our solution reduced the total carbon footprint by about 90%.
“In the first place, incinerating fossil fuel–based plastic releases carbon dioxide (CO2) into the atmosphere. With a plant-based material, CO2 release on incineration is offset by the CO2 the plants absorb from the atmosphere while they’re growing. Secondly — and this is where we get deep into the chemistry of the materials — PLA has less carbon in the polymer backbone, so incinerating an equivalent mass of PLA compared to fossil fuel–based plastic releases substantially less CO2. And finally, the Cell Screw creates a vessel with a large surface area in a small volume, so we use less raw material in its manufacture than in the equivalent surface area of Cell Stacks.
“Technically, PLA could be recycled, reducing its environmental impact still further, but the infrastructure to support that is not yet widely available. However, as PLA becomes more used in more applications, including food packaging, I’m optimistic that mainstream recycling will start to include PLA too. There are some suppliers already doing this; we’ve done some experiments to confirm that our lab waste is recyclable, so we know it’s possible.
“Once we released the first Cell Screw product, we realized that there was really an appetite within the industry for plant-based lab plastics that would help support a transition to sustainable research, so we decided to diversify our portfolio and see what other products we could make from PLA. We decided to start with a 96-well plate, because pretty much every lab around the world uses them, and in fact, the optical properties of PLA are again even more favorable than those of polystyrene. While polystyrene absorbs UV light, PLA doesn’t, and the rest of the light spectrum is comparable, so that PLA-based 96-well plates are suitable for microscopy, fluorescence, and most other standard assays. We’ve been testing the market for this product for around half a year now, and the customer response has been great — we’re onboarding distributors now.
“Ultimately, sustainability is a data game, which is something scientists are really good at. So rather than just focusing on what looks good on paper, it’s important to really understand the product streams, the waste streams, and the energy streams that are used and reduce where you have the biggest impact.”
Re-use: Ensuring Plastic Retains its Value as Part of a Circular Economy
It won’t be possible — at least in the near future — to eliminate fossil fuel–based plastic from laboratory workstreams entirely. But it may be possible to help many commonly used laboratory plastics retain their value as part of a circular economy. A linear economy is one that takes raw materials, manufactures them into products, and then disposes of them as waste. This type of economic model is commonly held to prioritize profitability ahead of sustainability, but ironically, as resources become scarce while demand continues to rise, the linear economy becomes unsustainable and ultimately strains profitability.16 A circular economy, however, aims to minimize waste by keeping raw materials within the supply chain through re-use or recycling. Grenova, a biotechnology company founded in 2014, has developed washing technology to transition pipette tips and microwell plates — some of the most commonly used and discarded laboratory plastics — from single to multi-use, therefore retaining their value within a circular economy.
“Most labs use autoclaves to sterilize reusable lab equipment,” explains Caitlin Harclerode, Senior Director of Marketing & Strategic Partnerships at Grenova, “which use heat as their primary form of sterilization. But this can ruin pipette tips and deform other polystyrene based plastics. Our TipNovus® and PlateNovus™ washing platforms work at room temperature and have four different cleaning steps. The first is a high-pressure flush, where water and cleaning agent flush through the tips (or plates) to remove large contaminants. Then UV light exposure kills 99% of infectious pathogens and ensures that tips/plates are DNA and RNA free. Tips are soaked in cleaning solution to loosen any additional particles before using sonication to remove any remaining small contaminants. Finally, mechanical agitation aids in the rinsing process by removing water droplets and reagent.
“After the washing process, the plastic is sanitized and can be used the same way that you would use a new pipette tip. When we install a new washer, we help the customer perfect their wash protocol. In most cases, customers validate the cleaning results to use the consumables up to 10 cycles, so the customer will be confident that they can use their tips, or plates, at least 10 times, and they’ll still be performing as new.
“In terms of environmental impact, we’ve partnered with a company called Rho Impact, a sustainability consultancy that develops data-driven ESG solutions, and we’ve worked with them to build a calculator that enables customers to calculate the impact that adopting our solutions would have on their business. We looked at carbon emissions, plastic waste, water usage, and cost. The cost is straightforward, because every time you wash a rack of tips, you save the cost of buying a new one. So even accounting for the initial CapEx investment, most customers see a return on their investment within two years.
“And then assuming that you reuse a tip rack an average of 10 times, we see about 90% savings on carbon emissions and plastic waste, compared with buying new each time. The manufacturing process for pipette tips is very water intensive because they use water to cool the plastic, so even though we use water for washing, it’s still a saving of about 4 L of water per tip every time you reuse it; equating to a total water saving of around 60% compared with manufacturing new.
“There’s no real limit to how you can use these washed tips. If you had your TipNovus® in a laminar flow hood, you could use the washed tips for cell culture, for example, but it’s really about what applications the customer is open to validating this technology in. We’ve seen a lot of adoption from within the food and agriculture industry.
The pharma industry generally takes a cautious approach; their sensitivity thresholds to new solutions are necessarily different, but it doesn’t have to be all or nothing. You can stair-step your way in; only wash pipette tips and plates from R&D or discovery labs or only wash tips that have been used for buffers, rather than anything potentially more toxic, for example. And then when you start to trust the technology, you can stair-step up to using it more widely.
“When it comes to sustainability, it is important to just start somewhere. Thinking about tackling the whole plastic waste problem in one go is overwhelming. So, start with something small and manageable. A rising tide raises all boats, after all.”
Recycle: Giving Laboratory Plastic a New Lease on Life
The other way to retain plastics within a circular economy is through recycling. Recycling laboratory plastic has not traditionally been a simple undertaking. There are health and safety concerns around contaminated materials entering the waste stream. Some products are made from mixtures of different plastics that can’t be recycled together if the recycled plastic is to retain its value. There’s a lack of waste management infrastructure to support biopharma plastic recycling, and there are questions about polymer degradation post-recycling downgrading the quality of the recycled plastic produced. There isn’t a silver bullet solution that can target all these issues in a single shot. However, from grass roots initiatives within individual labs, through start-ups focusing on changing biopharma waste management to large scale industry partnerships, efforts to increase the amount of laboratory plastic that can be recycled — and therefore reduce the volume of plastic sent to landfill or incineration — are well underway.
At one end of the spectrum, MilliporeSigma are tackling the very heart of biopharma’s plastic waste conversation — single-use manufacturing technologies. These are often made from mixed materials, such as silicone, polyethylene, and polypropylene, which are challenging to segregate. However, through a longstanding partnership with Triumvirate Environmental, MilliporeSigma have found a solution. Triumvirate grind, shred, separate, and sterilize the plastic in house before processing the material into industrial-grade plastic lumber, perfect to make products such as speed bumps, parking bollards, and palettes, at a cost comparable to that of incineration.17 However, the key to long-term success for this partnership is the ability to create new products from the recycled plastic that have a robust market for onward sale, something that Triumvirate are continuing to explore through evolving and refining their processes to increase the types of products they can manufacture.18
Laboratory plastic is typically of a very high grade, so for laboratory items made from a single type of plastic, sorting prior to recycling, so that the resulting recycled plastics retain their value, is ideal. UK start-up LabCycle has piloted a model for sorting, collecting, decontaminating, and recycling laboratory plastic from BSL-1 and BSL-2 labs and turning it into new laboratory consumables.
“I think some of the real barriers to recycling laboratory plastic is lack of understanding about what can actually be safely recycled, and then a lack of knowhow and scalable decontamination technology in the waste management industry” said Dr Helen Liang, Co-Founder and Chief TechnologyOfficer of LabCycle. “We have developed an automated decontamination system that can efficiently remove biological and chemical contaminants from the plastic and turn it into high-grade recycled plastic pellets that we then use to make new laboratory consumables, such as Petri dishes and test tubes.
“Compared to autoclaves, which uses high pressure and temperature to sterilize equipment, our decontamination system uses 93% less energy and 75% less water. We’ve validated our process at various different scales to ensure that the decontamination steps are effective. The decontamination process is technically effective up to Hazard Group 4, but regulations mandate that containers for those products be incinerated, so for now, we say that we can take any plastic waste up to Biosafety Level 2.
“However, a recycling program like ours will only work if we reduce the barriers to participation as much as possible. There has to be no excuse not to participate. So, we have a sorting system –– a set of relatively compact bins that sit inside the labs, which are very easy to use and able to segregate the different types of plastic properly. It takes one or two weeks to get used to it, but then it just becomes second nature. Our system is also cost-comparable to incineration, so there is really no downside for the customer. We are still at pilot scale, but we’ve already been working with customers from both the public and private sector –– the National Health Service (NHS), universities and private companies –– and there is so far a huge demand for what we’re doing. We’ve even had international interest already from the U.S. and Europe and have potential customers waiting for us to grow big enough that we can work with them.
“So, of course we’re already thinking about how to scale up. It’s important to keep all the operations as local as possible when we do to reduce transport requirements (and therefore carbon emissions), so our future model will involve establishing satellite hubs, to leverage as many partnerships and collaborations as possible.
“Right now, the products we make from the recycled plastic are manufactured in an ISO 13485 (medical devices) facility, and they are suitable for various research activities. We have been looking into medical device certification, which will enable the consumables to be used in pharmaceutical settings. There is some polymer degradation when you use extrusion or injection molding to make a new product, which could potentially affect the quality of the recycled plastic eventually, but this isn’t a big concern because for every piece of recycled plastic that comes back into our system to be recycled again, there will always be virgin plastic being recycled for the first time, enhancing the quality of the recycled material and ensuring that it stays fit for purpose for the consumables we’re manufacturing.”
Toward a More Sustainable Future for Biopharma
As the pharmaceutical industry makes strides to address their direct emissions (Scope 1) and put pressure on their energy suppliers to drive down their Scope 2 emissions, indirect (Scope 3) emissions will move increasingly into the spotlight. And building a circular economy to reduce the amount of plastic waste in pharma supply chains will need be a part of those conversations. Although reliable data about the exact amount of waste plastic generated by the pharmaceutical industry are difficult to find, there’s no doubt that the scale of the problem is enormous.
Change is slow. But it is necessary. And it is coming from multiple directions. Ms Harclerode says, “Regulation is forcing people to look at not just plastics but their environmental footprint in general and forcing suppliers to do the same. There’s going to be a natural cascade of expectations, which is exactly what we need to make this bigger impact.” Dr Eichmann adds, “Change is also being driven by investment. If you want to be in a green Exchange Traded Fund (ETF), you have to fulfil certain ESG commitments.”
“On the other hand,” he adds, “I see the younger generation being intrinsically motivated to improve sustainability — and a lot of people now in their 30s and 40s are, in general, living in a more sustainable way than our parents did. And this generation is now moving into positions of responsibility within the industry and getting the opportunity to step up and make an impact.”
Dr. Liang agrees that change isn’t always driven from the top down, “Grassroots initiatives keep people motivated and enforce action.” Dr. Eichmann sees this too within Green Elephant Biotech, “In daily life, and in the lab, it’s all small things coming together, all driven by our team themselves. And that’s really how I see sustainability working — not chasing a “net zero or nothing” solution but making small changes everywhere to reduce emissions by 30, 50, or 80% in every part of our lives.”
And whether it’s reducing, re-using, or recycling laboratory plastics, any and all of these initiatives are helping the biopharma industry create a healthier world, not just through the drugs they deliver to market, but in the way they develop and manufacture these lifesaving medicines.
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